Trial · NCT00758420

Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence

NCT00758420, Phase 2, Phase 3, Completed, Boston Scientific Corporation; results first posted 2014-03-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence. Trials, record NCT00758420. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00758420

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence
NCT number: NCT00758420
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 77 participants, actual
Lead sponsor: Boston Scientific Corporation
Conditions: Varicose Veins
Interventions: Varisolve (Polidocanol Endovenous Microfoam), Agitated Saline
First posted: 2008-09-25
Last updated: 2021-04-21
Results first posted: 2014-03-24

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks	Baseline to 8 weeks	The VVSymQ is a subset of the VEINES-Sym and consists of the 5 symptoms most relevant to patients. The raw score, which can range from 5 to 30, was transformed to a summary VVSymQ score that ranges from 0 (worst possible symptom health) to 100 (best symptom health) using the following formula: VVSymQ: (Transformed Score) = \[(Raw Score) - 5\] \* 4.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks	Baseline to 8 weeks		units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks	Placebo		16.7	Standard Error 3.18	units on a scale
The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks	Polidocanol Injectable Foam, 1.0%		30.7	Standard Error 3.04	units on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Active Treatment	39
Overall Study	STARTED	Placebo	38
Overall Study	COMPLETED	Active Treatment	39
Overall Study	COMPLETED	Placebo	38
Overall Study	NOT COMPLETED	Active Treatment	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events46

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	chest discomfort	General disorders	Placebo	0	38	0
other	chest discomfort	General disorders	Polidocanol Injectable Foam, 1.0%	2	39	2
other	edema	General disorders	Placebo	0	38	0
other	edema	General disorders	Polidocanol Injectable Foam, 1.0%	2	39	2
other	nasopharyngitis	Infections and infestations	Placebo	1	38	1
other	nasopharyngitis	Infections and infestations	Polidocanol Injectable Foam, 1.0%	2	39	2
other	contusion	Injury, poisoning and procedural complications	Placebo	2	38	2
other	contusion	Injury, poisoning and procedural complications	Polidocanol Injectable Foam, 1.0%	10	39	10
other	incision site complication	Injury, poisoning and procedural complications	Placebo	1	38	1
other	incision site complication	Injury, poisoning and procedural complications	Polidocanol Injectable Foam, 1.0%	3	39	3

1 to 10 of 46Source ClinicalTrials.gov

See all 46 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Polidocanol Injectable Foam, 1.0%
Total, other adverse events	Placebo	19	38
Total, other adverse events	Polidocanol Injectable Foam, 1.0%	36	39
Total, serious adverse events	Placebo	1	38
Total, serious adverse events	Polidocanol Injectable Foam, 1.0%	1	39

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27013511	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Polidocanol Injectable Foam, 1.0% vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00758420

GET https://conductscience.org/api/trials/v1/NCT00758420/events?page=2

API reference For AI assistants